Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118761255 | 11876125 | 5 | F | 2015 | 20160217 | 20151229 | 20160728 | EXP | CA-JNJFOC-20151221562 | JANSSEN | 53.74 | YR | A | F | Y | 89.00000 | KG | 20160728 | OT | CA | CA |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118761255 | 11876125 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FHM67012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 118761255 | 11876125 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FHM67012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 118761255 | 11876125 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FHM67012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 118761255 | 11876125 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FHM67012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 118761255 | 11876125 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FHM67012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 118761255 | 11876125 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FHM67012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 118761255 | 11876125 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FHM67012 | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 118761255 | 11876125 | 8 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FHM67012;FHM67012 | 103772 | 500 | MG | LYOPHILIZED POWDER | ||||||
| 118761255 | 11876125 | 9 | C | MESALAZINE | MESALAMINE | 1 | Unknown | 0 | 500 | MG | UNSPECIFIED | ||||||||
| 118761255 | 11876125 | 10 | C | MELATONIN | MELATONIN | 1 | Unknown | 0 | 3 | MG | UNSPECIFIED | ||||||||
| 118761255 | 11876125 | 11 | C | ATIVAN | LORAZEPAM | 1 | Oral | 0 | 1 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118761255 | 11876125 | 1 | Crohn's disease |
| 118761255 | 11876125 | 2 | Crohn's disease |
| 118761255 | 11876125 | 3 | Crohn's disease |
| 118761255 | 11876125 | 4 | Crohn's disease |
| 118761255 | 11876125 | 5 | Colitis ulcerative |
| 118761255 | 11876125 | 6 | Colitis ulcerative |
| 118761255 | 11876125 | 7 | Colitis ulcerative |
| 118761255 | 11876125 | 8 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118761255 | 11876125 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118761255 | 11876125 | Abdominal pain | |
| 118761255 | 11876125 | Arthropod bite | |
| 118761255 | 11876125 | Constipation | |
| 118761255 | 11876125 | Drug ineffective | |
| 118761255 | 11876125 | Fistula | |
| 118761255 | 11876125 | Frequent bowel movements | |
| 118761255 | 11876125 | General physical health deterioration | |
| 118761255 | 11876125 | Haematochezia | |
| 118761255 | 11876125 | Off label use | |
| 118761255 | 11876125 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 118761255 | 11876125 | 1 | 20160217 | 0 | ||
| 118761255 | 11876125 | 2 | 20151223 | 0 | ||
| 118761255 | 11876125 | 3 | 20150916 | 0 | ||
| 118761255 | 11876125 | 4 | 20150915 | 0 | ||
| 118761255 | 11876125 | 5 | 20160217 | 0 | ||
| 118761255 | 11876125 | 6 | 20150916 | 0 | ||
| 118761255 | 11876125 | 7 | 20150915 | 0 | ||
| 118761255 | 11876125 | 8 | 20151223 | 0 |